A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT04880850
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.
The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily.
Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants will get is decided by chance. Participants will also get a mealtime insulin.The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.
The study will last for about 8 months. participants will have 17 clinic visits and 13 phone calls with the study doctor.At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study.
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 582
- Male or female aged above or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2D) greater than or equal to 180 days prior to the day of screening.
- Glycated haemoglobin (HbA1c) from 7.0-10.0% (53.0 85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
- Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, insulin glulisine) greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to screening:
Metformin / Sulfonylureas / Meglitinides (glinides) / DPP-4 inhibitors / SGLT2 inhibitors / Thiazolidinediones / Alpha-glucosidase inhibitors / Oral combination products (for the allowed individual oral anti-diabetic drugs) / Oral or injectable GLP-1-receptor agonists
- Body mass index (BMI) below or equal to 40.0 kg/m^2.
- Any episodes (as declared by the subject or in the medical records.) of diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description insulin icodec + insulin aspart Insulin aspart Participants will get once weekly injections in combination with 2-4 times daily injections of insulin aspart Insulin glargine + insulin aspart Insulin glargine Participants will get once daily injections in combination with 2-4 times daily injections of insulin aspart Insulin glargine + insulin aspart Insulin aspart Participants will get once daily injections in combination with 2-4 times daily injections of insulin aspart insulin icodec + insulin aspart Insulin icodec Participants will get once weekly injections in combination with 2-4 times daily injections of insulin aspart
- Primary Outcome Measures
Name Time Method Change in Glycated haemoglobin (HbA1c) From baseline week 0 (V2) to week 26 (V28) Measured in %-point
- Secondary Outcome Measures
Name Time Method Change in fasting plasma glucose (FPG) From baseline week 0 (V2) to week 26 (V28) Measured in mmol/L
Change in body weight From baseline week 0 (V2) to week 26 (V28) Measured in kg
Time in target-range 3.9-10.0 mmol/L (70-180 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6) From week 22 (V24) to week 26 (V28) Measured in % of readings
Number of severe hypoglycaemic episodes (level 3) From baseline week 0 (V2) to week 31 (V30) Number of episodes
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) From baseline week 0 (V2) to week 31 (V30) Number of episodes
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) From baseline week 0 (V2) to week 31 (V30) Number of episodes
Time spent above 10 mmol/L (180 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6) From week 22 (V24) to week 26 (V28) Measured in % of readings
Time spent below 3.0 mmol/L (54 mg/dL) (using continuous glucose monitoring (CGM) system, Dexcom G6 ) From week 22 (V24) to week 26 (V28) Measured in % of readings
Mean weekly insulin dose From week 24 (V26) to week 26 (V28) Measured in U
Trial Locations
- Locations (81)
UT Southwestern Med Cntr
🇺🇸Dallas, Texas, United States
Noritake Clinic
🇯🇵Ushiku-shi, Ibaraki, Japan
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
Osvaldo A. Brusco MD PA
🇺🇸Corpus Christi, Texas, United States
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
🇧🇪Bonheiden, Belgium
CHU Helora - Site Warquignies
🇧🇪Boussu, Belgium
UZ Leuven - Endocrinology
🇧🇪Leuven, Belgium
Bethesda Diabetes Research Center en Bethesda ziekenhuis
🇳🇱Hoogeveen, Netherlands
Metabolic Research Institute Inc
🇺🇸West Palm Beach, Florida, United States
AM Diabetes And Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
Lifecare Hospital and Research Centre
🇮🇳Bangalore, Karnataka, India
Medanta - The Medicity Multi-Speciality Hospital, Gurugram
🇮🇳Gurgaon, Haryana, India
Bangalore Clinisearch
🇮🇳Bangalore, Karnataka, India
Azienda Ospedaliero-Universitaria Renato Dulbecco
🇮🇹Catanzaro, Cz, Italy
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
🇮🇹Napoli, Italy
Istituto Scientifico San Raffaele
🇮🇹Milano, MI, Italy
A. O. Universitaria S.ORSOLA-MALPIGHI - U. O. Endocrinologia
🇮🇹Bologna, Italy
Università degli Studi G. D'Annunzio
🇮🇹Chieti, Italy
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
Sasaki Hospital Internal Medicine
🇯🇵Hokkaido, Japan
Sugimoto Clinic,Internal Medicine
🇯🇵Kitakyusyu-shi, Fukuoka, Japan
Shimizu Clinic Fusa
🇯🇵Saitama, Japan
Oyama East Clinic
🇯🇵Tochigi, Japan
The Jikei University Hospital Dept of Diabetes, Metabolic
🇯🇵Tokyo, Japan
Hospital Universitario Dr. José Eleuterio González_Monterrey
🇲🇽Monterrey, Nuevo León, Mexico
Rijnstate Ziekenhuis
🇳🇱Arnhem, Netherlands
Centro de Investigacion Medica de Occidente S.C.
🇲🇽Zapopan, Jalisco, Mexico
Unidad Biomedica Avanzada Monterrey
🇲🇽Monterrey, Nuevo León, Mexico
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, Netherlands
Ikazia Ziekenhuis
🇳🇱Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Spitalul Judetean de Urgenta Targoviste
🇷🇴Targoviste, Dambovita, Romania
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
🇷🇴Bucharest, Bucurestii, Romania
Mariodiab Clinic SRL
🇷🇴Brasov, Romania
Sc Mediab Srl
🇷🇴Targu Mures, Mures, Romania
S.C. Medcon S.R.L
🇷🇴Buzau, Romania
Clinical Emergency Sf. Apostol Andrei Hospital
🇷🇴Galati, Romania
Tumen State Medical University
🇷🇺Tumen, Russia, Russian Federation
City Hospital #5
🇷🇺Barnaul, Russian Federation
Arkhangelsk Regional Clinical Hospital
🇷🇺Arkhangelsk, Russian Federation
KSFMU, Inrereginal Clinical Diagnostic center
🇷🇺Kazan, Russian Federation
Limited Liability Company "AriVa-Med"
🇷🇺Kursk, Russian Federation
Kirov Clinical Hospital #7
🇷🇺Kirov, Russian Federation
City Clinical Hospital â„–52
🇷🇺Moscow, Russian Federation
Limited Law Company "Healthy Family" Medicine Center"
🇷🇺Novosibirsk, Russian Federation
Regional clinical cardiology dispensary
🇷🇺Saratov, Russian Federation
Vanderbilt Diab Obes Clin Tri
🇺🇸Nashville, Tennessee, United States
Diabetes, Thyroid and Endocrine Centre
🇮🇳Jaipur, Rajasthan, India
John Muir Physicians Network
🇺🇸Concord, California, United States
Valley Research
🇺🇸Fresno, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Diabetes Research Center
🇺🇸Tustin, California, United States
Coastal Metabolic Research Center
🇺🇸Ventura, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Physicians Research Assoc. LLC
🇺🇸Lawrenceville, Georgia, United States
Jefferson City Medical Group, PC
🇺🇸Jefferson City, Missouri, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
Physician's East Endocrinology
🇺🇸Greenville, North Carolina, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
DCOL Ctr for Clin Res
🇺🇸Longview, Texas, United States
Methodist Physicians Clin
🇺🇸Omaha, Nebraska, United States
LLC "Centr Targetnoy Terapii"
🇷🇺Moscow, Russian Federation
SPb SBHI City Outpatient clinic #37
🇷🇺Saint-Petersburg, Russian Federation
MedStar Diabetes Institute
🇺🇸Washington, District of Columbia, United States
Saltzer Medical Group Research
🇺🇸Nampa, Idaho, United States
BSES MG hospital
🇮🇳Mumbai, Maharashtra, India
Policlinico Umberto I La Sapienza V Clinica Medica
🇮🇹Roma, Italy
Renai Medicity
🇮🇳Kochi, Kerala, India
Hayashi Diabetes Clinic
🇯🇵Chigasaki-shi, Kanagawa, Japan, Japan
UZA - UZ Antwerpen - Department of Endocrinology
🇧🇪Edegem, Belgium
Prince Aly Khan Hospital
🇮🇳Mumbai, Maharashtra, India
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
🇧🇪Bruxelles, Belgium
Futata Tetsuhiro Clinic Meinohama
🇯🇵Fukuoka-shi, Fukuoka, Japan
Manipal Hospital, Hebbal, Bengaluru
🇮🇳Bengaluru, Karnataka, India
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Texas Diab & Endo, P.A.
🇺🇸Austin, Texas, United States
Clinical Trials Research_Sacramento_0
🇺🇸Sacramento, California, United States
Texas Diabetes & Endocrinology
🇺🇸Austin, Texas, United States
Grant Medical Foundation
🇮🇳Pune, Maharashtra, India